None listed
Conditions
Brief summary
The purpose of this study is to examine the feasibility and safety of a device for ablating cancerous lung tumors using a technique called thermal vapor ablation. Who is it for? You may be eligible for this study if you are aged 18 or older and are a suitable candidate for resection of a lung cancer tumor. Study details All participants will receive one treatment of thermal vapor ablation via a bronchoscope (tube down the throat), 2-4 days before undergoing their scheduled surgical lung resection. The treatment takes place under general anaesthetic in a day surgery procedure area. All participants will be followed-up using standard hospital procedures. It is hoped that this research will provide information into the non-surgical treatments of lung cancer, thereby providing future non-surgery related options for the disease.
Interventions
Thermal Vapor Ablation delivered to target lung areas (Cancerous Lesions). Thermal Vapor Ablation involves the delivery of a measured dose boiling water to the area surrounding the cancerous lesion.
The Vapor ablation will be delivered by an interventional pulmonologist (respiratory physician) in a bronchoscopy suite within a hospital.
One dose of 330 calories of energy is delivered to targeted lung lesions (according to a CT guided therapy plan) during a single bronchoscopic procedure prior
Thermal Vapor Ablation delivered to target lung areas (Cancerous Lesions). Thermal Vapor Ablation involves the delivery of a measured dose boiling water to the area surrounding the cancerous lesion. The Vapor ablation will be delivered by an interventional pulmonologist (respiratory physician) in a bronchoscopy suite within a hospital. One dose of 330 calories of energy is delivered to targeted lung lesions (according to a CT guided therapy plan) during a single bronchoscopic procedure prior to lung resection. This procedure will generally take less than 30 minutes to perform. Lung resection will then occur according to the standard hospital procedures. Subjects will be treated with Thermal Vapor Ablation (BTVA-C) and the interval between ablation and resection will be a minimum of 60 hours to a maximum of 105 hours, with the exact scheduling determined by the investigator.
Sponsors
Uptake Medical Inc.
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age: equal to or greater than 18 years old 2. Non-small cell lung cancer tumor(s) equal to or less than 2cm in diameter (T1aN0, T1bN0, T1aN1, or T1bN1) suitable for resection OR Metastatic lung tumor(s) equal to or less than 2cm suitable for resection 3. Suitable candidate for resection per standard of practice 4. Microscopic proof of malignancy obtained. 5. Location of tumor: a. In periphery of lung (outermost one third) b. Anticipation that resection would remove all gross tumor and ablation with grossly negative margins c. Maximum of three vapor ablation applications would target entire margin according to the vapor ablation plan 6. Signed informed consent
Exclusion criteria
1. Centralized tumor not amenable to resection (abutting main stem bronchus, main pulmonary artery branches, esophagus, or trachea) 2. Carcinoid lung tumors 3. Tumor is associated with atelectasis or obstructive pneumonitis or pleural effusion 4. Pulmonary function tests (PFTs): post-bronchodilator forced expired volume in one second (FEV1) or forced vital capacity (FVC) < 50% predicted, diffusing capacity of the lung for carbon monoxide (DLCO) <50% predicted 5. Requirement for supplemental oxygen at rest or exercise 6. Hospitalization for cardiac disease within the preceding 6 months 7. Liver enzymes (ALP, ALT, AST) or total bilirubin > 1.5 upper limit of normal (ULN) 8. Serum creatinine > 2 mg/dl 9. Recent infection (within 30 days) 10. Receiving immunosuppressive medication or prednisone > 10 mg/day (or equivalent) 11. Pre-existing implants within the airways that impede navigation to the target lesion 12. Pregnant or breastfeeding women and those of childbearing potential who are not practicing a reliable form of contraception. 13. Disorder of coagulation, history of severe hemoptysis, or receiving anticoagulant medication. Antiplatelet medication is permitted provided that the medication can be held a minimum of 7 days prior to the procedure and 10 days, post-procedure. 14. Any condition that in the opinion of the investigator or reviewer may interfere with the safety of the patient or evaluation of the study objectives 15. Any tumor characteristic that in the opinion of the investigator or reviewers may interfere with the safety of the patient or evaluation of the study objectives
Outcome results
None listed